FDA Speaker Outlines a Novel Vision for Device Regulation

Although the U.S. regulatory process for medical devices is dedicated to protecting patients by setting high standards, the length of time and high costs associated with approval can stifle innovation, according to a keynote lecture yesterday in the Main Arena. 

Jeffrey E. Shuren, MD, JD, director of devices and radiological health at the U.S. Food and Drug Administration (FDA) in Washington, D.C., outlined a vision for improvements in the regulatory process that could reduce the time and costs of the product life cycle while maintaining safety and efficacy.

“We have a fabulous regulatory standard to market in the U.S.,” Shuren said. “But it is one of the highest standards in the world, and requires much more evidence to get to market to meet that standard than most other countries. As a result, innovators can be disincentivized to bring products to the U.S.”

The information age 

To this shift, Shuren proposed that innovators look to the incredible revolution in information and data that has occurred worldwide. he pointed out that, by some estimates, 90% of all the world’s data has been generated in only the past 2 years.“Massive amounts of data are generated every day as a part of routine health care, and we cannot make good use of it,” he said. The regulatory environment should begin to adapt to the new era of big data and endless information, Shuren said. He called the new direction toward which the FDA is moving a “learning medical device ecosystem,” based upon the concept of a neural network. Creation of this network would involve flexible regulatory paradigms, and a national evaluation system that strategically gathers and analyzes evidence from clinical experience.

With regard to flexibility, Shuren said that today’s regulators take technology and shoehorn it into the existing pathways of regulation, rather than designing new pathways around the technology. That must be reversed, he stressed. “The key here is looking at rational benefit-risk tradeoffs.” Instead of pre-market data gathering followed by post-market surveillance, the focus should be on broadening patient access based upon an evolving understanding of benefit and risk, Government must also learn to embrace more extensive deregulation of low-risk digital health technologies, adopting the attitude of “smart regulation when you need it, no regulation when you don’t,” he said.

Knowledge commons and surveillance 

The second ingredient to change is the creation of a “knowledge commons.” This method would make curated information available to the community in order to perform and accelerate research. Shuren referenced a 2014 FDA white paper that proposed creating curated genetic databases; this would possibly allow the clinical community to crowdsource data as an alternative to clinical trials. Next-generation sequencing is an example of a field where the traditional models of data gathering are not optimal, he noted.

Finally, the FDA has also proposed a national surveillance system, Shuren reported. It would involve all stakeholders in the system, from patients to clinicians to device companies. Surveillance could involve novel concepts, such as unique device identifiers on labels that are seamlessly integrated with information sources such as electronic health records.

The STS/ACC Transcatheter Valve Therapy Registry is an example of this new type of surveillance, Shuren noted, adding that this sort of approach can be leveraged to perform nesting clinical studies at far lower costs than with traditional models. The FDA in some cases has begun advising companies not to conduct post-approval studies, because the data are already being collected in these alternate forms, he said. Ultimately, Shuren acknowledged that it will take buy-in from all stakeholders in order to achieve true progress. “It takes an ecosystem,” he concluded.

Disclosures: 

• Shuren reports no relevant conflicts of interest.